Detection of Early Lung Cancer by Serum Protein Expression Profiling

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175578
First received: September 13, 2005
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

Promising new technology exists to examine small proteins that are shed by cancers into the blood stream. The purpose of this study is to see if there are differences in the proteins and protein levels in blood from individuals with early stage lung cancer compared to healthy adults.


Condition
Non-small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differences in SELDI Produced Serum Protein Profiles of Non-small Cell Lung Cancer Patients Compared to Healthy Heavy Smoking Adults

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Estimated Enrollment: 220
Study Start Date: May 2005
Estimated Study Completion Date: December 2011
Detailed Description:

A prospective longitudinal patient-based pilot study is proposed whereby surfaced enhanced laser desorption ionization time-of-flight mass spectroscopy (SELDI-TOF-MS) will be used to discover and validate serum proteomic expression profiles diagnostic of early lung cancer. A unique approach will be used to compare the serum proteomic expression profiles of patients with non-small cell lung cancer compared to healthy heavy smoking adults, as well as differences before and after anatomic pulmonary resection with curative intent. Discriminatory proteins will be selected by their differential expression before compared to after surgical removal of a tumor. The protein profile of blood obtained from the draining pulmonary vein at the time of resection will be used to identify materials potentially shed by the tumor that may serve as biomarkers in peripheral blood. The serum samples will be used to develop a training data set and then a test set for validation using a class prediction model. Candidate proteomic patterns will then serve as a basis for a larger prospective multi-centre clinical trial.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with non-small cell lung cancer and healthy heavy smoking adults.

Criteria

Inclusion Criteria:

  • Presence of early stage non-small cell lung cancer
  • Elective surgical resection of lung lesion at Vancouver General Hospital (VGH)
  • No preoperative chemoradiation therapy
  • No previous cancer
  • Ability to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175578

Contacts
Contact: Jennifer Rattenbury 604-875-4111 ext 62183 jrattenbury@shaw.ca

Locations
Canada, British Columbia
Vancouver General Hospital BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada
Contact: Jennifer Rattenbury    604-875-4111 ext 62183      
Principal Investigator: John Yee, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: John Yee, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175578     History of Changes
Other Study ID Numbers: C04-0640
Study First Received: September 13, 2005
Last Updated: November 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Early stage (0/I) non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014